The Government Response to the Health Committee Report on the Electronic Patient Record

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1 The Government Response to the Health Committee Report on the Electronic Patient Record Presented to Parliament by the Secretary of State for Health by Command of Her Majesty November 2007 Cm

2 The Government Response to the Health Committee Report on the Electronic Patient Record Presented to Parliament by the Secretary of State for Health by Command of Her Majesty November 2007 Cm

3 Crown copyright 2007 The text in this document (excluding the Royal Arms and departmental logos) may be reproduced free of charge in any format or medium providing that it is reproduced accurately and not used in a misleading context. The material must be acknowledged as Crown copyright and the title of the document specified. Any enquiries relating to the copyright in this document should be addressed to The Licensing Division, HMSO, St Clements House, 2 16 Colegate, Norwich NR3 1BQ. Fax: or

4 THE GOVERNMENT RESPONSE TO THE HEALTH COMMITTEE REPORT ON THE ELECTRONIC PATIENT RECORD iii Contents Introduction 1 Background 1 Programmes added to support NHS reforms 2 Existing NHS IT programmes incorporated into the National Programme 2 Programmes added to ensure integrated information 3 Programme added in response to the Cancer Strategy 3 Progress on the National Programme 3 Response to the Committee s recommendations 5

5 THE GOVERNMENT RESPONSE TO THE HEALTH COMMITTEE REPORT ON THE ELECTRONIC PATIENT RECORD 1 Introduction This Command Paper sets out the Government s response to the Health Select Committee s Sixth Report of the Session 2006/07 on the electronic patient record. Background The House of Commons Health Select Committee (the Committee) published its report into the Electronic Patient Record on 13 September This Command Paper sets out the Government s response to the conclusions and recommendations in that report. The Government welcomes the report s conclusions on the potential of electronic patient records to improve healthcare services and patient safety. In particular, it agrees with the Committee s view that the implementation of electronic patient records is a long journey best managed by a staged and piloted development not a big bang approach. The Government reaffirms its view that solid progress has been made on the delivery of the National Programme for IT in the NHS (the National Programme), though it accepts that delays have occurred to the delivery of some parts of the Programme. These delays are in many instances the consequences of taking longer over consultation and stakeholder engagement rather than simply delays in the production of software. In any event, the robustness of the contracts with suppliers means that the costs of any IT system delays have not been borne by the taxpayer. The Government recognises that continuing effort is needed to engage with frontline NHS staff and to communicate the Programme plans to the public. The central vision of the National Programme is to make essential patient information available at the point of need, through the NHS Care Records Service. Initially, the National Programme included the following major core components: an Electronic NHS Care Records Service to improve the sharing of patients records across the NHS with their consent; an Electronic Booking Service to make it easier and faster to book hospital appointments for patients; an Electronic Prescription Service; and a New National Network (N3) to provide a broadband IT infrastructure to ensure that NHS data transfer needs could be met now and in the future.

6 2 THE GOVERNMENT RESPONSE TO THE HEALTH COMMITTEE REPORT ON THE ELECTRONIC PATIENT RECORD Since its initiation, a number of programmes have been added to the scope of the National Programme, in order to: support NHS reforms; improve the delivery of existing NHS IT programmes; ensure that information is integrated; and support the Cancer Strategy. Programmes added to support NHS reforms In support of the policy on patient choice, which was set out in The NHS Plan (July 2000) and extended in Health Reform in England: Update and Next Steps (December 2005), the proposed Electronic Booking Service was extended to provide patient choice. It was renamed as Choose and Book. General practitioner (GP) contracts contain a Quality and Outcomes Framework of national achievement targets describing how GP practices are rewarded financially based on their achievements. The Quality Management and Analysis System (QMAS) was introduced to collect national achievement data, compute national disease prevalence rates and calculate the points and payment values earned by GP practices. QMAS also allows GP practices to analyse the data they collect about the services and quality of care they deliver. The National Programme has also been extended to support: Payment by Results, announced in NHS Financial Reforms: Introducing Payment by Results (October 2002); the 18 weeks delivery programme, announced in The NHS Improvement Plan (June 2004): By 2008 no one will wait longer than 18 weeks from GP referral to hospital treatment ; Practice Based Commissioning, announced in Health Reform in England: Update and Next Steps (December 2005); and NHS restructuring. Existing NHS IT programmes incorporated into the National Programme The following existing NHS IT programmes were incorporated into the National Programme: NHS Numbers for Babies, which issues an NHS number at birth, thereby enabling health episodes to be recorded on discrete personal records from the outset; and NHSmail, an and national directory service for all NHS staff which is secure and can be used for the transmission of patient and clinical data.

7 THE GOVERNMENT RESPONSE TO THE HEALTH COMMITTEE REPORT ON THE ELECTRONIC PATIENT RECORD 3 Programmes added to ensure integrated information The following programmes were incorporated into the National Programme because they provide the greatest value for patients when integrated with other components of the programme: Picture Archiving and Communication Systems (PACS), which are digital imaging systems that capture X-rays, computerised tomography (CT) scans and magnetic resonance (MR) scans electronically to aid diagnoses, were added to the National Programme in September PACS had previously been procured piecemeal by the NHS. The GP to GP Transfer System, which enables the electronic transfer of a patient record to the new GP practice when a patient changes their GP. Programme added in response to the Cancer Strategy In 2004, a national screening programme for bowel cancer was announced which would be implemented progressively across the country from April The Bowel Cancer Screening System supports this programme. Progress on the National Programme The National Programme has made significant progress since its inception. On a typical day in October 2007, there were: 250,000 prescriptions transmitted electronically, reducing errors and inefficiencies; 18,000 Choose and Book electronic bookings made, putting patients in charge of their care; over 1.4 million enquiries recorded on the Personal Demographics Service (PDS), enabling letters to be posted to the correct address and patient information to be handled more efficiently; over 1.7 million digital images stored on PACS; over 2,500 new users registered for access to the NHS Care Records Service; 52,000 unique, authenticated users accessing the NHS Care Records Service; over 1,500 new NHS secure users registered; over 120,000 NHSmail users, each of whom has an address for life, sending 1 million secure s, one-third of which contain confidential patient information; 54 NHS National Network secure broadband connections installed; nearly 9,000 GP practices (33,000 GPs) using QMAS to deliver better care to patients under the new GP contract; and 1.5 million records added to the Secondary Uses Service.

8 4 THE GOVERNMENT RESPONSE TO THE HEALTH COMMITTEE REPORT ON THE ELECTRONIC PATIENT RECORD In his interim report on the NHS Next Stage Review, Our NHS Our Future (October 2007), Professor the Lord Darzi of Denham FREng, KBE, FMedSci records that the NHS s recent investment in technology has created the opportunity to make a step change in the NHS. The introduction of the electronic patient record remains at the centre of this investment.

9 THE GOVERNMENT RESPONSE TO THE HEALTH COMMITTEE REPORT ON THE ELECTRONIC PATIENT RECORD 5 Response to the Committee s recommendations Recommendation (paragraph 116) The Committee is aware of the Department s most recent plans but is concerned that the complexity of the SCR appears to be increasing. This will make the SCR more difficult to use, particularly in emergency situations. The Department must be clear about the purpose of the SCR, and it must ensure that the record is easy to use. To this end, we recommend that the SCR include a single standardised front screen to display key health information which is vital for emergency care. The Government accepts this recommendation. The Summary Care Record (SCR) has been designed in consultation with clinicians working in urgent care settings. There is a single standardised front screen to display key health information which is vital for emergency care. The design has been agreed with the National Clinical Reference Panel. The functionality will allow this summary information to be viewed from within unscheduled care settings, for example accident and emergency departments, walk-in centres and out-of-hours services. The first information included in the SCR will be basic information such as known allergies, known adverse reactions to medications and other substances (for example, peanuts), prescriptions issued in the past six months and repeat prescriptions that are not more than six months beyond their review date. If the SCR is developed and augmented with additional information beyond that which is currently planned, then the redesign of the screen will be agreed through the same channels. Recommendation (paragraph 119) The Committee considers that much of the controversy over privacy and consent arrangements for the SCR would have been avoided if Connecting for Health had communicated its plans more clearly to patients. We recommend that Connecting for Health: Make clear to patients, clinicians and the public that detailed information will only be added to the SCR with explicit patient consent, that patients can see this information before it is added, and that patients can choose to have an SCR created but not accessed beyond their GP surgery; and Offer the same assurances to all patients in the SCR early adopter sites.

10 6 THE GOVERNMENT RESPONSE TO THE HEALTH COMMITTEE REPORT ON THE ELECTRONIC PATIENT RECORD The Government accepts these recommendations for the SCR early adopter programme, noting that initial work on communicating on privacy and consent in this area was carried out by both the NHS Information Authority and the NHS Modernisation Agency prior to their closure. In the early adopter programme, where the only source of data is the GP record, the creation of an SCR containing a person s current medication, allergies and adverse reactions is a matter of informed consent supported through a public information programme. Adding the patient s significant medical history occurs only through a discussion between the patient and their GP, as does the adding of information about new health episodes. The result of the approach taken is that patients are informed before the introduction of the SCR and may choose whether to have an SCR; may choose what is in it; may restrict who may see it; and may view it themselves through HealthSpace, a website with registration and access controls. All the published information makes it clear that patients have a choice and that the NHS will continue to provide the best care that it can, irrespective of whether patients have an SCR. However, the Department of Health will take all reasonable steps to ensure that these intentions are understood. The public information programme seeks to reach patients with timely information and support their choices before local implementation of the SCR and has therefore been focused on the early adopter sites. Experience in these sites will be evaluated independently and changes to the communications will be made where necessary. The SCR early adopter programme will provide experience and learning which will inform the SCR s future development, including the best ways of engaging individual citizens in the choices available to them. Recommendation (paragraph 121) Sealed envelopes are a vital mechanism if sensitive information is to be held on the SCR. We recommend that: The right to break the seal protecting information in sealed envelopes should only be held by patients themselves, except where there is a legal requirement to override this measure; and Information in sealed envelopes should not be made available to the Secondary Uses Service under any circumstances; this will allow patients to prevent data being used for research purposes without their consent. The Government accepts the first of these recommendations. Patient-sealed envelopes provide the mechanism whereby patients can restrict access to the parts of their SCR they consider to be particularly sensitive. Patients will be able to request that parts of their record are either sealed or sealed and locked. These procedures form a level of access control deployed at the direction of the patient, not the NHS.

11 THE GOVERNMENT RESPONSE TO THE HEALTH COMMITTEE REPORT ON THE ELECTRONIC PATIENT RECORD 7 Sealed information will be recorded on the SCR and system users will be aware that some information has been sealed. However, access to the sealed information from outside of the team recording it will be obtainable only with the patient s consent or in exceptional circumstances. Only those users with the necessary privileges will be able to gain temporary access to sealed information without the patient s consent. A privacy officer will be alerted to the temporary access by any user and patients registered with HealthSpace will receive a notification when access permissions are changed or when temporary access is gained. Sealed and locked information cannot be accessed outside of the team that recorded it. Users who do not have permission to access the sealed and locked information will be unaware of its presence. The circumstances where patient-identifiable sealed and locked information may be lawfully disclosed by the clinical team that has access to it, and the circumstances where patient-identifiable information that is simply sealed can be accessed by those outside of the team that recorded it, without the patient s consent, are essentially the same. They are limited to circumstances where the information is required by law or where a significant public interest justification exists (for example, serious crime, child protection etc). The Government does not accept the second of the recommendations. Patient consent to the use of anonymised or effectively pseudonymised data is not required by law and the use of such data for secondary uses, including research, is both accepted and actively promoted by the relevant professional and regulatory bodies. The Committee received strong evidence on the need for health information to be made available for research from a number of organisations. The design of the Secondary Uses Service ensures that patient confidentiality is protected. Recommendation (paragraph 122) HealthSpace is an excellent addition to the SCR programme and has huge potential to improve the safety and efficiency of care by allowing patients to check the accuracy of their SCR and to access detailed information about their own health. In order to take fuller advantage of HealthSpace, we recommend that Connecting for Health: Trial the use of HealthSpace for patients, particularly those with long-term conditions, to record their own measurements of key health information; Ensure that HealthSpace allows patients to view audit trails, showing who has accessed their SCR record and under what circumstances, and offers mechanisms for investigating inappropriate access; Promote the use of HealthSpace, monitor levels of uptake, and ensure that there is equitable access across the country and that coercive access is prevented; and Commission an independent evaluation of HealthSpace once the system is widely available.

12 8 THE GOVERNMENT RESPONSE TO THE HEALTH COMMITTEE REPORT ON THE ELECTRONIC PATIENT RECORD The Government welcomes the Committee s support for HealthSpace, which is a secure online personal health organiser where patients can store their personal health information, such as height, weight and blood pressure as well as viewing their SCR. The Government accepts in principle the recommendation to trial the use of HealthSpace for patients, particularly those with long-term conditions, to record their own measurements of key health information. NHS Connecting for Health has started work with the Patient Reference Panel to engage with patients with longterm conditions for this purpose and will work with the Long-term Conditions Alliance to agree the way forward. The Government accepts in principle the Committee s recommendation to ensure that HealthSpace allows patients to view audit trails, showing who has accessed their SCR and under what circumstances, and offers mechanisms for investigating inappropriate access. Facilities will be needed to enable patients to view details of who has accessed their records in line with the commitments of the Care Record Guarantee, and consideration will be given to how best to meet this and the other parts of the recommendation. The Government also accepts the recommendation to promote the use of HealthSpace, monitor levels of uptake, and ensure that there is equitable access across the country and that coercive access is prevented. NHS Connecting for Health already monitors the levels of take-up for each primary care trust (PCT). It is intended to monitor this further by relating the levels of take-up to each type of local publicfacing communications activity and to analyse the demographic details of advanced account users. NHS Connecting for Health also monitors its helpdesk activity for reports of coercive access, though to date none have been received. The Government agrees in principle with the Committee s recommendation for an independent evaluation of HealthSpace once it is widely available. Recommendation (paragraph 123) We note that in France patients will own their national summary record. This approach gives patients more control over who can access their record and more opportunity to influence and take control of their own care. We therefore recommend that Connecting for Health consider a similar model for the SCR in England. The Government accepts the principle of patient control of a national SCR and HealthSpace will be a key enabler in this process. However, the Government is unable to accept that the means to achieve this is to put control of the record through a separate health insurance card.

13 THE GOVERNMENT RESPONSE TO THE HEALTH COMMITTEE REPORT ON THE ELECTRONIC PATIENT RECORD 9 The fundamental differences in funding method between the French and English healthcare systems require different models. The French system requires patients to authorise access to their Personal Health Record (PHR) using their health insurance card. This is driven in part by the fundamentally insurance-based French healthcare system; treatment is not free at the point of delivery of care, in contrast to the English system, and the patient pays for treatment, reclaiming the cost from insurance funds (generally the state insurance scheme). The fundamental rationale is therefore that any (non-emergency) treatment requires the specific authorisation of the patient, whereas in the UK funding is a background process handled internally by the NHS and invisible to the patient. In the UK, the fact of registration with a GP practice is the basic authority for access to the health record and payment for any treatment. Although there are some specific differences between the French PHR and the English SCR (for example, the dual card approach), the controls over access to the information stored are similar in the two systems in that: both have concepts of role-based access, that is what information a clinician can see depends on their specific role, for example doctor, nurse, etc; information in the PHR can be hidden at the patient s request and only made available on the patient s specific authorisation (equivalent to the sealed envelope ); only authorised clinicians can enter health information (patients can add their own additional notes); there is provision for clinician access without patient authority in an emergency; and the French cards use electronic signatures to authenticate users in a manner comparable with cards issued to healthcare professionals by the National Programme. The Government believes, therefore, that the safeguards for patients are in fact similar in both countries but that the differences in the systems necessarily reflect differences in the way healthcare is provided. Recommendation (paragraph 125) However, serious concerns were expressed regarding the lack of information both about how security systems will work and about the outcomes of security testing. We agree with these concerns and recommend that Connecting for Health ensure that BT s planned security systems for its national applications are subject to independent evaluation and that the outcomes of this are made public. The Government accepts the major part of this recommendation. It accepts and already complies with the principle of independent testing by specialist third-party organisations and evaluation of security arrangements. However, it does not agree that the detail of the outcome should be made public as there would be a risk of compromising security arrangements and, potentially, criminal exploitation of information if details of the testing became public.

14 10 THE GOVERNMENT RESPONSE TO THE HEALTH COMMITTEE REPORT ON THE ELECTRONIC PATIENT RECORD The National Programme has adopted the highest levels of security. The National Programme s contracts require suppliers to comply with comprehensive and detailed security requirements including security penetration testing and compliance with international standards (ISO-27001). Suppliers are obliged to report any breach of the security requirements and to make recommendations for the remedy of any breach. NHS Connecting for Health may call in a third party to monitor its suppliers and make reasonable recommendations in the event of a breach and/or escalate the matter for dispute resolution if the remedy proposed by the supplier is not acceptable. In the event of a breach of security incapable of remedy or that is not remedied, NHS Connecting for Health has the right to terminate the relevant contract immediately without paying compensation to the supplier. Security testing of national applications is therefore already subject to independent evaluation and conclusions are acted upon. Recommendation (paragraph 126) Maintaining the operational security of the new SCR system is a substantial challenge. We acknowledge that Connecting for Health and its suppliers have made significant efforts to minimise the risk of operational security breaches. Individual smartcards, rigorous user authentication, role-based access controls, legitimate relationships and audit trails will all help to increase operational security, both individually and in combination. However, many of these measures are new and untested on the scale that they will be used in the NHS. As a result, their impact and vulnerabilities are difficult to predict. We therefore recommend that Connecting for Health: Ensure that the evaluation of the early adopter sites examines both the individual and the collective impact of the new operational security measures for the SCR, commissioning a separate evaluation if necessary; and Undertake a program of operational security training for all staff with access to the SCR, emphasising the importance of not divulging information to those who request it under false pretexts. The Government welcomes the recognition of the work done by NHS Connecting for Health and its suppliers to minimise risks and accepts the Committee s recommendations. The Government confirms that the evaluation of the early adopter sites will include an assessment of the impact of the operational security measures for the SCR. Emerging findings from the evaluation will feed into the further implementation of the SCR within early adopter communities and will also inform the national implementation of the SCR from 2008 onwards. As part of the early adopter programme, a rolling programme of training is in place for all NHS staff on security and confidentiality issues of the SCR. This is in addition to routine training on the use of IT, data protection and confidentiality requirements for patient information. Relevant lessons from the evaluation will be incorporated.

15 THE GOVERNMENT RESPONSE TO THE HEALTH COMMITTEE REPORT ON THE ELECTRONIC PATIENT RECORD 11 Recommendation (paragraph 127) Operational security also depends on effective enforcement. The Department of Health and the Information Commissioner s Office have called for custodial sentences for people who unlawfully access personal information. The Committee welcomes this, and recommends that a substantial audit resource be provided to detect and prosecute those who access the system unlawfully. The Government accepts the principle of this recommendation and believes that the necessary processes for prosecution are in place. NHS Connecting for Health has supported the Information Commissioner s call for custodial sentences for unlawful access to personal information to strengthen the deterrent. NHS Connecting for Health places the highest importance on safeguarding patient information through numerous information governance controls within the systems deployed and information assurance practices across all organisations using the National Programme s digital services. NHS Connecting for Health works closely with the Department of Health and the Healthcare Commission to ensure that healthcare organisations using National Programme systems maintain standards to ensure that patient information is not accessed unlawfully. Organisations and individuals using systems supplied by NHS Connecting for Health must abide by set conditions controlling access to and use of those systems. These mechanisms, which are already in place, ensure that only appropriately authorised NHS personnel, with an appropriate role and an established legitimate relationship with the patient, can access confidential patient information in the NHS. Compliance with these organisational and individual obligations is monitored regularly using online assessment tools and a national audit framework; alerts are generated automatically when attempts are made to transgress these controls. In some exceptional cases, access controls to patient information can be overridden due to a court order, access by statute or in the public interest. In these cases, alerts are raised through the system to the nominated privacy officer, who will ensure that the action taken by the user is justified and lawful. Recommendation (paragraph 229) Yet there is a perplexing lack of clarity about exactly what NPfIT (National Programme for IT) will now deliver. It is not clear what information will be recorded and shared on DCR (Detailed Care Record) systems, nor the range of organisations that will be able to share information. Suppliers told us there will be significant variation between the size of different areas. The Department stated that DCR systems may be confined to areas as small as a single hospital or as large as an entire SHA. While local control over the new systems is a desirable goal, it is surprising that the architects of the DCR were not able to provide a clearer vision of what is planned. There is an explanatory vacuum surrounding DCR systems and this must be addressed if duplication of effort at a local level is to be avoided. We recommend that Connecting for Health:

16 12 THE GOVERNMENT RESPONSE TO THE HEALTH COMMITTEE REPORT ON THE ELECTRONIC PATIENT RECORD Publish clear information about its plans for DCR systems, stating in particular what area will be covered by shared records and what degree of information sharing will be possible; these plans should make reference to the original specifications for the Integrated Care Records Service, making clear how the scope of the project has changed since 2003; and Set out clear milestones for achieving the increasing levels of interoperability and automation offered by DCR systems. The Government accepts these recommendations. There have been changes to NHS organisational boundaries and a review of the information-sharing arrangements is already under way with strategic health authorities (SHAs) and suppliers. This aims to ensure that the patient benefits from information sharing across care settings are preserved while also ensuring resilience and flexibility for organisational purposes and local management reporting. The evaluation of the SCR will be helpful in establishing future plans. A maturity model of secondary care settings already exists which describes the opportunities for moving from systems being linked simply by interfaces to interoperable systems that can move patient data between national, local and existing departmental systems, and ultimately to fully integrated systems. Suppliers are being asked to map their proposals against the maturity model with key milestone dates. Recommendation (paragraph 233) We recommend that Connecting for Health: Ensure that all LSPs publish detailed timetables for delivering new PAS [Patient Administration System] applications, electronic prescribing systems and shared local record systems, indicating what level of information sharing will be possible when DCRs are first implemented; and Set a deadline for the successful deployment of the Lorenzo system in an NHS hospital, making clear that if the deadline is not achieved then other systems with similar capability will be offered to local hospitals. The Government accepts these recommendations. Initially, the National Programme developed detailed implementation plans covering a long forward period but a combination of factors, including software development, implementation issues and NHS operational needs, led to changed dates and uncertainty. Experience shows that, when a trust is maintaining essential patient services during an implementation, there must be some flexibility and movement in dates to account for local circumstances. Following the report by the National Audit Office, the approach has been modified. Responsibility for deployment, including planning and timetabling, has now been transferred to the local NHS, who agree the deployments with suppliers in line with the suppliers capacity and their local NHS business circumstances and implementation slots. This ensures that local circumstances are taken into account and both the NHS and suppliers are involved in deployment decisions. This is therefore removing much of the earlier uncertainty for trusts.

17 THE GOVERNMENT RESPONSE TO THE HEALTH COMMITTEE REPORT ON THE ELECTRONIC PATIENT RECORD 13 Although the delays to the delivery of the Lorenzo system have been disappointing for the NHS, deployments are scheduled for early adopter sites in the summer of Recent demonstrations of the Lorenzo product to NHS clinicians and managers confirm that it meets the requirements and expectations of the NHS and provides improved confidence that the current planned timetable will be achieved. The NHS and suppliers are working together to ensure that Lorenzo can be delivered within the terms and life of the contract. Recommendation (paragraph 234) In light of a range of concerns, including the delays to elements of the DCR programme, a number of witnesses called for an independent review of the whole of NPfIT. Whilst we understand the reasons for this, we do not agree that a comprehensive review is the best way forward. First, many of the questions raised by the supporters of a review would be addressed if Connecting for Health provided the additional information and independent evaluation which we recommend in this report. Secondly, the programme has already been scrutinised by the National Audit Office, the Public Accounts Committee and ourselves. We therefore recommend that: The implementation of DCR systems be addressed in the short term by increasing both the local ownership and the professional leadership of the programme; and The ongoing review by Lord Darzi on the future of the NHS include in its remit the long-term prospects for using electronic systems to improve the quality of care, particularly for the growing number of patients with longterm conditions. The Government is pleased that the Committee recognises that a comprehensive review of the Programme at this stage is not necessary and accepts fully the recommendations. Local ownership is now being achieved through the NPfIT Local Ownership Programme (NLOP) initiated by the Chief Executive of the NHS in September Under NLOP, SHA chief executives became accountable as senior responsible owners (SROs) for the implementation of DCR systems in their SHA from April Governance processes are now in place to ensure that system requirements and deployment plans are developed and owned at local level with professional leadership and expertise in commercial management, IT and programme management being provided by NHS Connecting for Health. The London Programme for IT (LPfIT), the Southern Programme for IT (SPfIT) and the North, Midlands and East Programme for IT (NMEPfIT) each have programme directors now in place to improve the professional leadership of the Programme at a local level for each supplier. Local ownership is also addressing the issues of standardisation and common ways of working while, at the same time, catering for specific local NHS needs. This will address some of the problems that the NHS and suppliers have experienced over a lack of standardised processes to date.

18 14 THE GOVERNMENT RESPONSE TO THE HEALTH COMMITTEE REPORT ON THE ELECTRONIC PATIENT RECORD Following the publication of Lord Darzi s interim report, Our NHS Our Future, the NHS Chief Executive has ordered a review of information across the health service. Recent investment in technology in the NHS has created the opportunity to make a step change in how the NHS uses information. The NPfIT has connected every hospital and GP surgery to a common secure network. Clinicians now see benefits from the implementation of digital access to X-rays and scans (PACS) and new IT systems are going into primary, community and hospital settings. However, while the NHS has a great deal of data, it lacks meaningful information. Much of the information is available to limited numbers of people, often inconsistent with that held elsewhere, and frequently not available at the point of need. A key part of the review will be to bring together the data collected by the NHS and other organisations to maximise value, reduce any bureaucracy and ensure that patients, staff and the public can access the information they need. This is not a specific review of the NPfIT or of NHS Connecting for Health. It is a broader investigation into how the NHS can improve the collection and sharing of information including statistics, performance data and patient information, including long-term care to improve the quality of healthcare for patients. Recommendation (paragraph 236) There are already signs of a change of approach to increase local ownership of system implementation. Accountability is being devolved through the NPfIT Local Ownership Programme and control for some users is being increased through GP Systems of Choice. These measures are welcome but overdue. There is a need to go further and faster with reforms of this type. We recommend that: Connecting for Health devolve responsibility for performance managing implementation of all NPfIT systems to Strategic Health Authorities (SHAs); SHAs devolve responsibility for operational deployment by giving individual hospital trusts control over implementing their own new systems. SHAs should also devolve responsibility for implementing shared record systems across local health communities to their constituent Primary Care Trusts (PCTs); SHAs, PCTs and hospital trusts be given the authority to negotiate directly with LSPs and to hold suppliers to account, so that local organisations are not given responsibility without power; and Connecting for Health offer all local organisations a choice of systems from a catalogue of accredited suppliers, as far as this approach is possible within the limitations of existing contracts. The Government accepts the first of these recommendations. As already stated, SHAs now have accountability for managing implementation of the IT systems provided by local service providers. In respect of the national applications (for example, the N3), accountability remains with NHS Connecting for Health.

19 THE GOVERNMENT RESPONSE TO THE HEALTH COMMITTEE REPORT ON THE ELECTRONIC PATIENT RECORD 15 The second recommendation is assumed to relate to responsibilities for the implementation of applications provided under the National Programme s contractual arrangements. In this respect, the Government considers that the devolution of responsibilities by SHAs, to individual hospital trusts and PCTs, is a matter for determination by the local NHS within the existing governance arrangements that have been developed to support the local ownership programme. The spirit of the third recommendation is met by individual PCTs and hospital trusts being able to deal directly with suppliers in respect of implementations and being responsible for signing off systems at a local level before payment is made. The programme directors for the South, London, and the North, East and Midlands are responsible for dealing directly with suppliers in respect of requirements and wider planning across SHAs. NHS Connecting for Health remains responsible for commercial matters within the governance of the South, London, and North, East and Midlands Programme Boards. There is no intention to change the contractual arrangements. The central procurement exercise and management focus are the foundations for the work done so far and the value for money that the contracts offer, as well as achieving the technical requirements for interoperability. Through the NLOP, the Department of Health will ensure that SHAs, PCTs and trusts, working together with NHS Connecting for Health, are in a position to hold their local service providers to account and participate fully in negotiations with them. The fourth recommendation is partly met by GP Systems of Choice and there are already over 100 existing IT systems that have been accredited to link with national and local systems within the programme. Within the limits of the contracts and available resources, NHS Connecting for Health will continue to work with suppliers of existing systems to extend accreditation and compliance and to publicise the current status of accredited suppliers. Recommendations (paragraphs 237 and 238) Connecting for Health s own role should switch as soon as possible to focus on setting and ensuring compliance with technical and clinical standards for NHS IT systems, rather than presiding over local implementation. Clear standards would allow systems to be accredited nationally but would also ensure that local trusts have a choice of system and control over implementation. Technical standards should cover system security and reliability but should focus in particular on ensuring full interoperability between accredited systems. Comprehensive interoperability standards should guarantee that data can be seamlessly exchanged between systems whilst ensuring that users are not committed to a single supplier. In order to develop transparent technical standards, we recommend that Connecting for Health: Establish an independent technical standards body responsible for setting the interoperability requirements for data exchange for all systems deployed in the NHS. These standards should be published and subjected to full external scrutiny;

20 16 THE GOVERNMENT RESPONSE TO THE HEALTH COMMITTEE REPORT ON THE ELECTRONIC PATIENT RECORD Require all system suppliers to the NHS to meet and demonstrate conformity with these standards. Systems should be kite marked or classified to give details of their compatibility; and Work with industry and academia to establish an independent technical standards testing service to evaluate and accredit systems for use in the NHS. Much of what the Committee proposes is already in place. Devolvement of accountability to SHAs for implementation of the National Programme s systems means that NHS Connecting for Health is no longer presiding over local implementation. NHS Connecting for Health already focuses on setting and ensuring compliance with technical and clinical standards for NHS IT systems. The creation of The Messaging Service (TMS) as an atomic approach to record generation as part of the Spine architecture has been key to enabling over 100 million messages per month to be handled effectively across the systems. The use of standard HL7v3 messages throughout the systems has been a fundamental enabler. Only compliant systems that are approved and accredited are permitted to connect to the Spine. NHS Connecting for Health s National Integration Centre provides the main compliance mechanism to demonstrate integration of national, local and existing systems and assures the testing of systems that integrate via the NHS National Spine. This assurance covers not only the technical implementation, but also the patient safety and business practices of the organisation that is seeking compliance. These arrangements provide a comprehensive perspective on interoperability standards and promote development of those standards. NHS Connecting for Health, for example, has taken a leading role in establishing and developing the International Health Terminology Standards Development Organisation (IHTSDO) to secure the long-term strategic effectiveness of Systematized Nomenclature of Medicine (Clinical Terms) (SNOMED CT) terminology not just for the NHS but for the broader UK and international community. An independent standards body is in place. The Information Standards Board (ISB) is responsible for assuring and ensuring NHS information standards. These standards are published and subjected to full external scrutiny by a broad range of expertise, including clinical and academic reviewers independent of the programmes of work that deliver applications using the standards and independent of the standards development process. There is a contractual requirement for suppliers to utilise ISBapproved standards. The Government believes that these arrangements meet the recommendations and already involve industry, academia and professional bodies. It should be remembered that progress on the electronic health record on a national basis was virtually non-existent until the Programme was established and substantial numbers of deployments have been achieved since.

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